A wound resulting from a surgical procedure or the like often produces fluid, commonly referred to as exudate, which needs to be drained away from the wound site for proper healing and recovery of the wound. Wounds of this nature either are closed at the end of the surgical procedure or will close in the course of the body's natural healing process. Closure of the wound creates a need for a means to drain the fluid therefrom to promote satisfactory healing. A variety of catheter drain devices have been developed over the years to address this need.
Wound drain devices have typically comprised a drain section of a length of tubing perforated with small holes through the tubing wall. Fluid from the wound enters the tubing through the small holes and travels away from the wound within the tubing lumen. Problems exist, however, with this basic solution, including the likelihood of the tubing lumen clogging on the one hand with debris and/or new tissue ingrowth entering through the small holes and on the other hand by structural weakness in the walls of the tubing forming kinks and the like.
The above-mentioned inadequacies of the basic wound drain device have encouraged the development of a variety of improved designs. U.S. Pat. No. 4,398,910 to Blake et al. discloses a wound drain device having a central core with four strut portions projecting radially therefrom. The strut portions are equal in size and are spaced at equal angles relative to one another. The periphery of the wound drain is in the form of a plurality of overhang portions provided at the end of each of the four strut portions, thereby forming four T-shaped members. The overhang and strut portions cooperate to form four longitudinal lumens extending the length of the drain. Gaps between the overhang portions permit fluid entry into the lumens and are sized to inhibit new tissue from growing and debris from passing therethrough. The Blake et al. wound drain device, in comparison to other prior art drains, has increased tissue contact and luminal flow drainage areas designed to increase the level of drainage and to prevent clogging in the draining process and has an increased drain body cross-sectional area to increase the strength of the drain body. U.S. Pat. No. 4,465,481 to Blake discloses a single piece wound drain catheter, which is intended to improve upon the design disclosed in the above-described patent to Blake et al. (U.S. Pat. No. 4,398,910) by providing a single continuous elongate member of silicone material having a drain segment, a transition tube segment and an extension tube segment. The Blake et al. (U.S. Pat. No. 4,398,910) wound drain device needs to be connected to a separate outflow tube and thus has a point at which the strength of the tubing might be reduced. Problems exist, however, with the Blake et al. (U.S. Pat. No. 4,398,910) and Blake (U.S. Pat. No. 4,465,481) designs in that they allow for a single point location downstream for each longitudinal lumen to clog and do not distribute suction evenly over the length of the drain.
Also, U.S. Pat. No. 4,523,920 to Russo discloses a surgical suction drain device including a pair of spaced apart flanges with a web disposed therebetween having a single longitudinal lumen with apertures formed transversely through the flanges and intersecting the lumen. The problem with this device, however, is that inhibition of proper fluid drainage may be likely to happen by there being only one lumen provided and needed to become clogged.
Other wound draining devices have been developed which provide a fluid suction component. U.S. Pat. No. 4,508,533 to Abramson discloses a surgical drain device with a triple lumen catheter body, a three-tube connector interfit with the catheter body at the proximal end and adapted to provide a suction port, an irrigation port and an air intake port, a suture means to anchor the drain, and a softened portion at the distal end of the catheter body to facilitate insertion of the drain into the body and to reduce pressure to surrounding tissue. A problem exists, however, with having three lumens in this design in that fluid may back up in the second lumen and have the effect of clogging an antibacteria filter connected thereto and the second lumen would lose its effectiveness in providing a venting effect. Three lumens also require a large opening in the wound which may lead to discomfort for the patient. In an attempt to provide a solution to these problems with three lumens, U.S. Pat. No. 4,573,965 to Russo discloses only two lumens in its wound draining device. The first lumen is used for applying suction to a wound area. A check valve element and an antibacteria filter are positioned in-line communication with a second lumen to prevent backflow of fluids through the second lumen into the filter. It is notable that each of these devices with suction components have lumens perforated with holes which provide communication between the lumen and the wound. The problem here is that these holes may have a tendency to lead to the above-mentioned clogging problem of debris and/or new tissue ingrowth within one of the lumens.
Furthermore, U.S. Pat. No. 4,650,463 to LeVeen et al. discloses a perforated tubing for surgical drainage applications and the like. The tubing is comprised of a body having a central passageway in a clover-leaf cross-sectional appearance with four longitudinally extending grooves spaced at ninety degree arcuate intervals about the body. Perforations interconnect the grooves with the passageway. The perforations are in the form of a series of holes in the bottoms of the grooves. The perforations provide a means of more even distribution of suction over the length of the tubing. Problems exist, however, with this design in that several components are required to make it functional to support compression of tissue and the inhibition of proper fluid drainage may be likely to happen by there being only one lumen provided and needed to become clogged.
Another design, U.S. Pat. No. 5,116,310 to Seder et al., discloses a wound drain catheter formed by multiple parallel lumens to convey fluid from a wound. The design includes holes and at least one longitudinal slot extending interiorly from the outside surface which admits fluids into the lumens and internal holes to divert fluid from blocked lumens. The internal holes allow alternative drainage between lumens. A problem exists, however, with the external holes and slots in that they are susceptible to new tissue ingrowth. Hence, the Seder et al. device is an improvement on the above-mentioned Blake devices relative to drainage but does not alleviate the issues associated with tissue ingrowth.
Consequently, a need still exists for a wound drain which provides an efficient and comprehensive solution to the aforementioned problems in the prior art devices without introducing any new problems in place thereof.